Deformable fastener system

ABSTRACT

The guidance and positioning device may be a system for creating a passage in tissue, positioning fasteners or other implants, and tensioning an elongated fastening member, like a suture, thread, wire, or pin. In some embodiments, the device may allow for the implantation of multiple sutures and fasteners in tissue. A fastener may be positioned at the distal end of a flexible pushrod. The fastener may be connected with the pushrod or may be loosely fitted with the distal end of the pushrod. A suture may be looped through or connected with the fastener such that one, two, or more sections, legs, strands, or portions of the suture extend from the fastener.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.11/202,294 filed Oct. 5, 2005, entitled “APPARATUS AND METHODS FORSURGERY”, which is incorporated herein by reference in its entirety

FIELD

The invention relates to apparatus and methods for surgery. Morespecifically, the invention relates to the guidance and positioning oftissue, an implant, or other surgical devices within the body.

BACKGROUND

In the medical arts, physicians use various methods and devices toattach soft tissue to other soft tissue, soft tissue to hard tissue, andhard tissue to other hard tissue. These same or similar techniques anddevices are also used to position or fix an implant within the body.Such implants may include bone plates, fasteners, stents, filters, drugeluting implants, tissue alignment members, organ transplants, tissuescaffolding, tissue grafts, intervertebral disc replacement components,nucleus pulposus replacement component, and other joint replacementscomponents, prostheses, robotic components, nanotechnology devices,sensors, emitters, radiofrequency emitting diodes, computer chips, RFID(radiofrequency identification) tags, adhesives, and sealants.

Applying pressure or compression to tissue and/or an implant helpsduring the healing process. Incised or torn soft tissue, for example,may be approximated with bandages, sutures, or staples. Proper and morerapid healing of broken or fractured bones likewise may be facilitatedby applying constant pressure to the bone. For instance, physicians mayinsert pins, screws, or bolts in the area of the fracture in order toapply compression and stabilization to the fracture.

However, inserting screws through or around fractures can be complex andtime-consuming. For example, the process of inserting a screw typicallyinvolves multiple steps conducted from multiple incisions or openingsthat provide access to the treated bone or tissue, including the stepsof drilling holes, measuring the relevant distances to determine theappropriate screw selection, tapping the hole to establish threads, andscrewing the screw into the hole.

In addition to the length and complexity of the process, bone screwsalso may lose their grip and strip out of the bone. Also, currentlyavailable lag screws typically provide only one side of cortex fixationand are generally not suited for percutaneus surgery. Moreover, whenplacing the screws in the bone, the physician may not accurately set thescrew into the distal hole or may miss the distal hole completely,thereby resulting in the screw stripping the threads or breaking thebone.

Many devices and instruments have been disclosed to fasten soft and hardtissue for enhanced healing or tissue reconstruction. Examples of suchdevices include bone plates, bone wraps, external bone supports, and thelike.

For example, U.S. Pat. No. 4,257,411 to Cho discloses a surgical drillguide tool adapted to be temporarily mounted about a distal portion ofthe femur for drilling a bony tunnel through a portion of the femur. Thesurgical tool allows for very precise location of the drill exit withinthe intercondylar notch, which is often critical in properreconstruction of the anterior cruciate ligament of the knee. Thesurgical tool drill guide is characterized by having a first and secondupright, with first and second drill sheaths located at their respectivedistal ends wherein transverse mounting means are provided to allow thesurgeon to position the first and second drill sheaths tightly againstopposite surfaces of the femur to provide a continuing and exactalignment for the drilling of the bony tunnel. The drill sheath at thedistal end of the second upright is configured to fit inside theintercondylar notch, and allow exact placement of the exit of a bonytunnel which is drilled extra-articularly through the skin, and throughthe lateral femoral condyle.

U.S. Pat. No. 4,922,897 to Sapega et al. discloses a method andapparatus for the permanent surgical reconstruction of the anteriorcruciate ligament in the human knee, which will stabilize the tibia andfemur relative to each other and restore a full range of motion to theknee, by precisely locating the ends and angular relationship of areplacement ligament within the knee joint, at bone attachment sitessuch that the degree of shortening and lengthening experienced by thereplacement ligament over the range of joint motion is either as closeto zero (isometric) as possible, or closely matches that of the naturaluninjured ligament (physometric), whichever the surgeon feels is mostdesirable.

U.S. Pat. No. 5,573,538 to Laboureau discloses ancillary instruments forthe reconstruction of a posterior cruciate knee ligament by drilling oneor two tibial canals using a surgical operation performed from thefront. The instrument set includes a system for protecting the posteriorsurface of the upper tibia end and an aiming device for guiding at leastone drill. The protection system includes at least one bent tuberemovably coupled by an extension portion to a locking handle forsecuring the tube through the intercondylar fossa of the femur on theposterior surface of the upper end of the tibia, so that the distal endof the bent tube serves as the stop to the drill guided by the aimingdevice and emerging from the tibial bone canal, and the bent tube canform, together with a rectilinear wire feed-through tube disposed in theplace of the drill, a continuous canal for guiding a metallic loop usedto draw the prosthetic posterior cruciate knee ligament from theanterior surface of the tibia to the femur insertion point.

U.S. Patent Publication No. 2003/0216742 to Wetzler et al. discloses asurgical drill guide generally including a handle connected to an armwith an end that contacts bone. The handle has a plurality ofnon-parallel channels therein for receiving a sleeve at differentangles. Once properly positioned, the sleeve can be used to guide aK-wire into the bone, which can then be used as a guide for drilling atunnel. The various angles allow the surgeon to achieve a range oftunnel lengths. In some embodiments, the guide has a locking mechanismfor locking the sleeve in the channels.

Accordingly, a need exists for a method and device which can provideguided positioning and flexible or rigid fixation of tissue and/or animplant within the body while accessing the procedure site from a smallskin portal.

SUMMARY

The present invention provides an instrument and method for guiding andpositioning various implants within the body. The instrument may providefor the placement of a biocompatible implant within tissue and/or mayprovide for dynamic and rigid fixation of tissue. An implant guidanceand positioning device includes a body member connected with a hook. Thehook may have a lumen extending therethrough. The device also includes aguide channel disposed in the body member. The longitudinal axis of theguide channel may be generally aligned with or slightly offset from adistal end of the hook. The device may further include a pushrod forpositioning a fastener and suture in the lumen of the hook. Furthermore,the device may include an elongated claw dimensioned for insertionthrough the guide channel. The claw may include means for grabbing thesuture.

In another embodiment, the positioning device includes a body member, anelongated member connected with the body member, a socket memberconnected to the distal end of the elongated member, and a guide slotdisposed in the body member. The longitudinal axis of the guide slot isgenerally aligned with or slightly offset with the socket member. Thesocket member may be dimensioned and configured for holding a fastener.The device may also include a fastening member dimensioned for insertionin the guide slot. The fastening member may include means for attachingthe fastening member to the fastener, such as threads, ribs, magnets,adhesives, or expandable material.

In a related aspect of the present invention, the distal portion of thehook or elongated member is curved to be positionable at least partiallyon the distal or backside of the bone or tissue, while the proximalportion of the hook or elongated member may be generally parallel withthe guide channel or slot. The hook or elongated member may beremoveably connected with the body member with means for holding andreleasing the hook or elongated member.

The positioning device may further include a drill system having a drillbit dimensioned for insertion through the guide channel or slot. Thedrill system may create a linear or non-linear passage in tissue. Thedrill system may be a cannulated drill system. The positioning devicemay also include means for clamping the device to tissue. Such means mayinclude a threaded tube adjustably attached to the body member, a tubeand a finger grip attached to the body member, or one or more pinsplaced between the positioning device and tissue. Furthermore, thedevice may include a tensioning mechanism for tensioning the suture orfastening member.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention, and theattendant advantages and features thereof, will be more readilyunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings wherein:

FIG. 1 shows an exemplary embodiment of the guidance and positioningdevice of the present invention;

FIG. 2 illustrates a cannulated drill system inserted in the device;

FIG. 3 shows a pushrod configured for inserting a fastener and sutureinto a hook of the positioning device;

FIG. 4 illustrates a fastener and suture positioned in the hook;

FIG. 5 shows a suture claw positioned in the guide channel of thedevice;

FIG. 6 illustrates the suture claw withdrawn from the guide channel withthe suture disposed in the guide channel;

FIG. 7 shows the suture connected with the fastener on the distal sideof the bone and the suture extending from the drill system;

FIG. 8 illustrates a fractured bone with the suture extendingtherethrough;

FIG. 9 shows a fastener positioned on the proximal side of the bone andsecured to the suture;

FIG. 10 illustrates another embodiment of the implant guidance andpositioning device;

FIG. 11 shows a cannulated drill system disposed in a guide slot of thedevice;

FIG. 12 illustrates a fastener disposed in a socket on the distal end ofa hookshaped member of the device;

FIG. 13 shows a fastening member positioned in the guide slot of thedevice;

FIG. 14 illustrates a threaded distal portion of the fastening memberdisposed in a threaded hole of the fastener;

FIG. 15 shows a fractured bone with the fastening member extendingtherethrough;

FIG. 16 illustrates a fastener positioned on the proximal side of thebone and secured to the fastening member;

FIG. 17 shows one embodiment of a clamping mechanism of the device;

FIG. 18 illustrates another embodiment of the clamping mechanism of thedevice;

FIG. 19 shows an embodiment of a tensioning mechanism of the device;

FIG. 20 illustrates a drill/sleeve combination in accordance with thepresent invention;

FIG. 21 is a cross sectional view of FIG. 20;

FIG. 22 shows the drill/sleeve combination in use to repair a fracturedbone;

FIG. 23 illustrates the sleeve positioned across the fracture of thebone;

FIG. 24 shows another exemplary embodiment of the drill/sleevecombination;

FIG. 25 is a cross sectional view of FIG. 24;

FIG. 26 illustrates the drill/sleeve combination functioning as afastener;

FIG. 27 shows an exemplary distal portion of the fastener;

FIG. 28 illustrates another exemplary distal portion of the fastener;and

FIG. 29 shows another embodiment of the guidance and positioning devicehaving multiple hooks and guide channels.

DETAILED DESCRIPTION

The present invention provides an instrument and method for guiding andpositioning tissue and/or an implant within the body. The instrument mayprovide for the placement of a biocompatible implant within tissue ormay provide for dynamic and rigid fixation of tissue. The device canaccess and treat a fractured, incised or torn tissue, or the like, fromone access area (i.e., from only one opening to the tissue to befastened) instead of requiring two or more openings. That is, the deviceis a linear system that can be used with a single, small incision orportal in the skin or other soft tissue to gain access to the tissue,for example a fractured bone.

The guidance and positioning device may be an all-in-one system forcreating a passage in tissue, positioning fasteners or other implants,and tensioning an elongated fastening member, like a suture, thread,wire, or pin. In some embodiments, the device may allow for theimplantation of multiple sutures and fasteners in tissue with little orno repositioning of the device. For example, the device may have two ormore of the elements described below connected to a single grip orhandle. Likewise, the incision or opening providing access to thetreated bone or tissue may extend at least partially in a directionalong the length of the treated area so that the processes describedbelow may be repeatedly performed on other, nearby portions of the boneor tissue in a similar manner.

Tissue Repair

Referring now to the drawing figures in which like reference designatorsrefer to like elements, there is shown in FIG. 1 an exemplary embodimentof the guidance and positioning device 20. The device includes agenerally cylindrical handle 22 and a hook 24 with a proximal endconnected to the handle 22. In one embodiment, the hook has a tubularconstruction. An interior passageway may extend from the proximal end tothe distal end. The hook 24 may be curved as illustrated in the Figures,may be angular (e.g., may have an open-sided geometric shape), or mayhave any other desired shape so that its distal end is disposedapproximately around the bone or tissue to be treated or fastened.

The proximal portion of the hook 24 may be positioned generally parallelwith the longitudinal axis of the handle 22. A plurality ofinterchangeable hooks 24 may be releasably and interchangeably connectedto the handle. In this manner, hooks of different sizes, shapes, orother features may be selected and used as desired by a physician. Thus,the device 20 may have a lever, clip, set-screw, button, spring, match,or latch 26 that allows selective securing and releasing of hooks 24 toor from the handle 22. The lever 26 allows different sized hooks 24 tobe placed in the handle 22. For example, the hook may include differentsized lumens extending therethrough, may be different lengths, and/ormay have different radii of curvature. The curved or angled portion 28of the hook 24 may be configured for positioning around a fractured bone30 (as seen in FIG. 1), multiple pieces of similar tissue, multiplepieces of different tissue, or a single tissue element. Examples of suchtissue includes, not is not limited to, bone, muscle, cartilage,ligament, tendon, skin, etc. Also, the tissue may be stomach tissue, andthe positioning device may be used during bariatric surgery, likegastric stapling. It is further contemplated that measurements such asthe depth, angle, length, and/or compression of the hook be determined.The handle may include guides or indicia for measuring and displayingthese measurements. Alternatively, the positioning device may includesensors for taking these measurements. For example, the handle of thedevice may include sensors and/or radiofrequency transmitters fordetermining and sending measurements to a computer and/or display.

A guide channel 32 extends through the handle 22. Preferably, the guidechannel 32 extends generally parallel with the longitudinal axis of thehandle 22. The longitudinal axis of the guide channel 32 is generallyaligned with or is slightly offset from the distal end 34 of the hook24. For instance, the shortest distance between the longitudinal axis ofthe guide channel and the distal end of the hook may be about 2 cm orless. In other embodiments, the shortest distance may be about 1 cm orless, or even about 0.25 cm or less.

Preferably, the guide channel 32 and hook 24 are configured so that thedevice can be used with a single, small incision in the skin or othersoft tissue to gain access to the fractured bone or other tissuerequiring fixation. For example, the portions of the guide channel 32and hook 34 that are near the opening or incision may be spaced apartfrom each other by about 5 cm or less, and preferably are spaced about 2cm or less from each other near the incision or opening. In oneembodiment, the guide channel and hook are generally parallel andrelatively close to each other for a substantial portion of the distancebetween the handle and the incision or opening.

In use, the device 20 is positioned with the curved portion 28 of thehook 24 placed next to and around the tissue to be fastened. The hookmay be positioned subcutaneously, percutaneously, and/or minimallyinvasively. The tissue may be a fractured bone, a tissue fragment havingtendon and bone or ligament and bone, or a tissue with avulsion typefragments. In FIG. 2, a curved portion 28 of the hook 24 is placedaround a fractured bone 30 (fracture not shown) or tissue. A drillsystem 36 is positioned in the guide channel 32. The drill system 36includes a headpiece 38 configured for attachment to a drill 40. A drillbit 42 is positioned at the distal end of the drill system 36. A drillstop 44 is located distal from the headpiece 38 and prevents the drillbit 42 from penetrating too far beyond the tissue to be drilled. Thedrill system 36 may be a cannulated drill system. A cannula or sleeve 46may encircle the drill bit 42 or at least the shaft portion of the drillbit 42. As the drill bit 42 creates a passage 48 through the bone 30,the sleeve 46 is positioned in the passage 48 to link the bone passage48 and the guide channel 32. The drill system 36 is used to create apassage 48 in the bone 30 from the proximal side of the bone 30 to thedistal side of the bone 30, then the drill 40 and drill bit 42 areremoved from the sleeve 46 and guide channel 32. The distal opening ofthe bone passage 48 is generally near the distal aperture 50 of the hook24.

It is contemplated that the drill system may be used to create anon-linear passage in tissue. The non-linear passage may be formed to goaround implants such as an intramedullary rod or prosthesis. Thenon-linear passage may also allow a physician to avoid critical bodyparts or tissues such as vessels or organs. Alternatively, no drillsystem may be employed to create a passage in the tissue. Rather, asdescribed in more detail below, the guide channel may be used to guideand position a self-introducing elongate member like a guide wire,k-wire, claw, grabber, etc. The self-introducing member may be forcedthrough the soft or hard tissue instead of pre-drilling a passage.

Next, as seen in FIG. 3, a fastener 52 is positioned at the distal endof a flexible pushrod 54. The fastener 52 may be connected with thepushrod 54 or may be loosely fitted with the distal end of the pushrod54. A suture 56 is looped through or connected with the fastener 52 suchthat one, two, or more sections, legs, strands, or portions of thesuture 56 extend from the fastener 52. Examples of fasteners may befound in U.S. Pat. Nos. 5,163,960 and 5,593,425 entitled “SurgicalDevices Assembled Using Heat Bondable Materials” which disclosefasteners assembled from a plurality of discrete components, one ofwhich includes a heat bondable material for bonding the componentstogether. The heat bondable material is preferably a polymeric orcomposite material suitable for surgical applications and implantationin the human body. The heat bondable material may be a biodegradablematerial. A laser, hot air gun, welding gun, soldering gun, or Bovie tipmay be used as a heat source for bonding the fastener. U.S. Pat. No.6,368,343 entitled “Method of Using Ultrasonic Vibration to Secure BodyTissue” further discloses using ultrasonic vibration energy to bond theheat bondable material of the components of the fastener.

U.S. Pat. No. 5,403,348 entitled “Suture Anchor” discloses an anchor forsecuring a suture in the body. The anchor includes a tubular wall havinga central axis. The tubular wall has a proximal end and a distal endeach free of axially inwardly extending slots. The tubular wall also hasan inner surface extending for the entire length of the tube anddefining in the anchor a central opening extending between the proximalend and the distal end. The anchor has a width less than its length. Asuture may extend through the anchor within the central opening. Firstand second end portions of the suture extend out of opposite ends of theanchor and are sufficiently long to project out of the body when thesuture is secured in the body by the anchor. The anchor has an anchoringorientation in the body achieved by manipulation of the distal end ofthe anchor by pulling on the second end portion of the suture.Furthermore, the anchor has a removal orientation in the body achievedby manipulation of the proximal end of the anchor by pulling on thefirst end portion of the suture.

U.S. Pat. No. 5,464,426 entitled “Method of Closing Discontinuity inTissue” discloses a suture anchor having a generally cylindricalconfiguration with a lumen extending therethrough. In use, a suture isinserted through openings in a plurality of anchors. Pulling on thesuture presses the anchors against the body tissue and presses the bodytissue together. The anchors may be pushed through the body tissue witha pusher member or by pushing the anchors against each other.

U.S. Pat. No. 5,549,630 entitled “Method and Apparatus for Anchoring aSuture” discloses a tubular anchor having a polygonal cross-sectionalconfiguration with flat outer side surfaces areas connected by aplurality of outer corner portions. A passage through the anchor may beformed by flat inner side surfaces interconnected by inner cornerportions. A suture is inserted through the passage. A concentrated forcemay be applied against a limited area on a trailing end of the anchor torotate the anchor to move an outer corner portion of the anchor intoengagement with body tissue. The suture may engage an inner cornerportion of the anchor. The suture may be inserted through a plurality ofanchors and the anchors moved through a tubular member into the bodytissue under the influence of force transmitted from a trailing anchorto a leading anchor. When the leading anchor is moved into the bodytissue, it is rotated under the influence of force applied against atrailing end of the leading anchor. If desired, two anchors may beinterconnected. A groove may advantageously be provided along theleading end and side of an anchor to receive the suture.

U.S. Pat. No. 5,713,921 entitled “Suture Anchor” discloses a sutureanchor formed from body tissue. The body tissue is shaped to a desiredconfiguration for the anchor and defines a passage through the anchor. Asuture is inserted into the passage in the body tissue of the anchor.The anchor is then positioned in a patient's body with a sutureextending into the passage in the anchor. The anchor may be formed ofosseous body tissue, hard compact bone, dense connective body tissue, orother body tissue. The body tissue may be dried so that it absorbs fluidand expands upon being inserted into a patient's body.

U.S. Pat. No. 5,718,717 also entitled “Suture Anchor” discloses ananchor formed of a material which absorbs body liquid when exposed tobody liquid. The anchor may be at least partially formed of a materialhaving a strong affinity for body liquids. This enables the anchor toabsorb body liquid and expand upon being inserted into a patient's body.At least one embodiment of the suture anchor has portions formed of arelatively hard material which does not absorb body liquids and ispressed against body tissue by the material which absorbs body liquid tomechanically interlock the suture anchor and the body tissue. The anchormay be at least partially formed of a cellular material. The cellsexpand to absorb body liquid. At least one embodiment of the anchor hasa pointed leading end portion to form an opening in an imperforatesurface on body tissue. The configuration of the anchor may be changedby tensioning the suture while the anchor is disposed in body tissue.

U.S. Pat. No. 5,782,862 entitled “Suture Anchor Inserter Assembly andMethod” discloses a suture anchor inserter assembly including a manuallyengageable handle and a shaft which extends axially outward from thehandle. The shaft includes an inner member which is fixedly connectedwith the handle and an outer member which is retractable into thehandle. An anchor is received in a chamber formed at the outer end ofthe shaft.

U.S. Pat. No. 5,814,072 entitled “Method and Apparatus for Use inAnchoring a Suture” discloses a suture anchor inserter including amanually engageable handle and a shaft which extends from the handlethrough a passage in the anchor. During insertion of the anchor intobody tissue, an end portion of the shaft pierces the body tissue inadvance of the anchor. At the same time, a pusher surface on the shaftapplies force against a trailing end portion of the anchor to push theanchor into the body tissue. When the orientation of the anchor is to bechanged, rotational force is applied to the anchor by tensioning thesuture and pressing the end portion of the shaft against an innersurface of the passage in the anchor.

U.S. Pat. No. 5,814,073 entitled “Method and Apparatus for Positioning aSuture Anchor” discloses an inserter assembly operable between a closedcondition blocking movement of a suture anchor through the inserterassembly and an open condition in which the inserter assembly isineffective to block movement of the anchor.

U.S. Pat. No. 5,845,645 entitled “Method of Anchoring a Suture”discloses a process of fastening a suture to an anchor. The suture isinserted through passages which are spaced apart along and extendtransversely to a longitudinal central axis of an anchor. When theanchor is moved into body tissue, a first portion of the suture extendsfrom the first passage in the anchor through an opening in the bodytissue to a location disposed to one side of the body tissue. A secondportion of the suture extends from the second passage in the anchorthrough the opening in the body tissue. The suture is tensioned to applyforce to the anchor. The force applied to the anchor by the sutureinitiates tipping of the anchor and movement of an end surface on theanchor across a leading end surface on an inserter member.

U.S. Pat. No. 5,921,986 entitled “Bone Suture” discloses an anchorconnected with a suture moved through a passage between opposite sidesof a bone. The anchor is then pivoted to change its orientation. Asecond anchor is connected with the suture. While tension is maintainedin the suture, the suture is secured against movement relative to theanchors. This may be done by tying the suture or by using a sutureretainer to hold the suture. A suture retainer may be used in place ofthe second anchor.

U.S. Pat. No. 5,948,002 entitled “Apparatus and Method for Use inPositioning a Suture Anchor” discloses an apparatus which includes atubular outer member and an inner or pusher member. During assembly ofthe apparatus, a suture is positioned in a slot in the outer member.During use of the apparatus, the slot facilitates visualization of theposition of the suture anchor relative to body tissue. In addition, theslot facilitates separation of the apparatus from the suture after thesuture anchor has been positioned in the body tissue. A suture anchorretainer may be provided at one end of the tubular outer member to gripthe suture anchor and hold the suture anchor in place during assembly.The tubular outer member may be utilized to guide a drill duringformation of an opening in body tissue and may be subsequently utilizedto guide movement of a suture anchor into the opening in the bodytissue.

U.S. Pat. Nos. 6,010,525; 6,159,234; and 6,475,230 entitled “Method andApparatus for Securing a Suture” disclose improved method to secure asuture relative to body tissue. A suture retainer is moved along firstand second sections of a suture toward the body tissue. When apredetermined minimum force is being transmitted between the sutureretainer and the body tissue, the first and second sections of thesuture are gripped with the suture retainer by plastically deformingmaterial of the suture retainer. The material of the suture retainercold flows under the influence of force applied against the surfaceareas on the suture retainer. One or more bends are formed in each ofthe sections of the suture to increase the holding action between thesuture retainer and the sections of the suture. The bends may be formedby wrapping a turn of the suture around a portion of the sutureretainer. During movement of the suture retainer toward the body tissue,the bends are moved along the first and second sections of the suture.

U.S. Pat. No. 6,045,551 entitled “Bone Suture” discloses an anchorconnected with a suture moved through a passage between opposite sidesof a bone. The anchor is then pivoted to change its orientation. Asecond anchor is connected with the suture. While tension is maintainedin the suture, the suture is secured against movement relative to theanchors. This may be done by tying the suture or by using a sutureretainer to hold the suture. A suture retainer may be used in place ofthe second anchor. The passage may extend across a fracture in the bone.The passage may have either a nonlinear or linear configuration. Atubular member may be positioned in the passage with the tubular memberextending into portions of the passage on opposite sides of thefracture. Opposite end portions of the tubular member may be disposed ina compact outer layer of the bone. If desired, a member other than asuture may be used as a force transmitting member between the twoanchors. The tubular member may be formed of bone.

U.S. Pat. No. 6,447,516 entitled “Method of Securing Tissue” discloses aretainer member formed of bone which secures tissue against movementrelative to a portion of a bone in a patient's body. The retainer memberis utilized to form an opening in a compact outer layer of a portion ofthe bone in the patient's body. The retainer member formed of bone isadvantageously enclosed in a tubular member or sleeve to preventbreaking of the retainer member during the forming of the opening in thebone. The extent of movement of the retainer member into the bone in thepatient's body is determined as the retainer member is moved into thebone. A suture may be connected with the retainer member and used toconnect tissue with the bone.

U.S. Pat. No. 6,592,609 entitled “Method and Apparatus for SecuringTissue” discloses an anchor having a pointed end portion may be utilizedto form an opening in a bone in a patient's body. The anchor is movedinto the opening formed in the bone in the patient's body with a sutureconnected to the anchor. The suture may then be utilized to retain bodytissue in a desired position relative to the bone. The body tissue maybe either hard or soft body tissue. If desired the anchor may beutilized in conjunction with layers of soft body tissue. When a sutureis used it may be secured by connecting a retainer with the suture.Alternatively, sections of the suture may be interconnected. It isbelieved that it may be preferred to secure the suture in place after atleast a predetermined tension has been established in the suture and/ora predetermined force has been transmitted to the body tissue. Thesuture may be secured in place by exposing a retainer to ultrasonicvibratory energy or by applying the ultrasonic vibratory energy directlyto sections of the suture.

U.S. Pat. No. 6,635,073 entitled “Method of Securing Body Tissue”discloses a process to secure a first body tissue with a second bodytissue. A first anchor is moved along a first path through the firstbody tissue into the second body tissue. A second anchor is moved alonga second path through the first body tissue into the second body tissue.A suture extending between the anchors may be tightened by moving thesecond anchor along a path which extends transverse to the path of thefirst anchor. The suture which extends between the anchors may have freeends which are connected with a suture retainer. The free ends of thesuture may be interconnected either before or after the anchors aremoved along the first and second paths. Alternatively, the suture may bea continuous loop which extends between the two anchors. A guideassembly may be provided to guide movement of the anchors along the twopaths. The paths along which the anchors move may intersect so that theanchors may be interconnected at the intersection between the two paths.

U.S. Pat. No. 6,719,765 entitled “Magnetic Suturing System and Method”discloses an instrument and method for passing a medical implementthrough tissue with magnetic forces. The implement can be an implant,either permanent or temporary, and is provided with a magneticcomponent. A magnetic field is established and the magnetic componentand/or magnetic field is manipulated to drive the implant throughtissue. Alternatively, the instrument itself is the implement andincludes at least one magnetic element so that a magnetic fieldestablished by an external magnetic generator drives the instrumentthrough tissue. In another embodiment, the instrument includes twomagnetic elements that are moveable with respect to one another andinteraction between the magnetic elements drives the instrument throughthe tissue. Examples of applications of the present invention include asuture passer and a tissue anchor.

Other fastener types and fastening methods are disclosed in U.S. patentapplication Ser. No. 10/102,413 entitled “Methods of Securing BodyTissue” which discloses an improved method of securing body tissueperformed with a robotic mechanism. The robotic mechanism may beutilized to tension a suture with a predetermined force and urge asuture retainer toward body tissue with a predetermined force.Ultrasonic vibratory energy may be transmitted to the suture retainer toeffect a gripping of the suture by the suture retainer. The body tissuemay be secured with a staple. Legs of the staple may be bonded togetherto secure the staple. The legs of the staple may be bonded together bytransmitting ultrasonic vibratory energy to the legs of the staple. Atissue positioning assembly may be used to hold the body tissue in adesired position. Images of the body tissue being secured may beobtained using various known devices including one or more endoscopes, afluoroscope, a magnetic resonance imaging device, and/or other knownimaging devices.

U.S. patent application Ser. No. 10/228,855 entitled “Apparatus andMethod for Securing a Suture” discloses a suture retainer having anupper or cover section and a lower or base section which cooperate todefine passages through which portions of a suture extend. Projectionson the cover section of the retainer extend into recesses on the basesection of the retainer. A center projection on the base section extendsbetween the two projections on the cover section. The projectionscooperate with surfaces on body sections of the cover and base sectionof the retainer to position and grip portions of the suture. Theretainer may be moved along the portions of the suture while theretainer is gripped by an applicator assembly. The applicator assemblyis operable to apply energy to the retainer to bond end portions of theprojections on the cover section to bottoms of recesses in the basesection of the retainer.

U.S. patent application Ser. Nos. 10/779,978; 10/780,444; and 10/797,685entitled “Method and Device for Securing Body Tissue” disclose suturesand suture retainers positioned relative to body tissue. Energy, such asultrasonic vibratory energy, is utilized to heat the suture retainer andeffect a bonding of portions of the suture retainer to each other and/orto the suture. Portions of the body tissue may be pressed into linearapposition with each other and held in place by cooperation between thesuture and the suture retainer. The suture retainer may include one ormore portions between which the suture extends. The suture retainer mayinclude sections which have surface areas which are bonded together. Ifdesired, the suture may be wrapped around one of the sections of thesuture retainer. The suture retainer may be formed with a recess inwhich the suture is received. If desired, the suture retainer may beomitted and the sections of the suture bonded to each other.

The characteristics and features of the fasteners and fastening methodsjust described may be combined and integrated with the devices andmethods of the present invention. The above cited patents and patentapplications are incorporated herein by reference.

Furthermore, the fasteners may be, but are not limited to, degradable,biodegradable, bioerodible, bioabsorbable, mechanically expandable,hydrophilic, bendable, deformable, malleable, riveting, threaded,toggling, barbed, bubbled, laminated, coated, blocking, pneumatic,one-piece, Morse taper single piece, multi-component, solid, hollow,polygon-shaped, pointed, locking and unlocking, self-introducing,knotless, and combinations thereof. Also, the fasteners may includemetallic material, polymeric material, ceramic material, compositematerial, body tissue, synthetic tissue, hydrophilic material,expandable material, compressible material, heat bondable material,biocompatible adhesive, and combinations thereof. Examples of bodytissue include bone, collagen, cartilage, ligaments, or tissue graftmaterial like xenograft, allograft, autograft, and synthetic graftmaterial. The fasteners may also be made from a porous matrix or mesh ofbiocompatible and bioresorbable fibers acting as a scaffold toregenerate tissue.

The fasteners may also be made of or have a coating made of anexpandable material. The material could be compressed then allowed toexpand. Alternatively, the material could be hydrophilic and expand whenit comes in contact with liquid. Examples of such expandable materialsare PEEK, ePTFE, and desiccated body tissue. It is contemplated that thefasteners and implants of the present invention may include anycombination of materials and agents disclosed herein. For example, afastener may include combinations of hydrophilic material, syntheticbody tissue, collagen, synthetic collagen, heat bonded material,biocompatible adhesive, and cells, such as stem cells.

Moreover, the fasteners described herein and incorporated by referencemay include therapeutic substances to promote healing. These substancescould include antibiotics, hydroxypatite, anti-inflammatory agents,steroids, antibiotics, analgesic agents, chemotherapeutic agents, bonemorphogenetic protein (BMP), tissue inductive factors, demineralizedbone matrix, collagen, growth factors, autogenetic bone marrow,progenitor cells, calcium sulfate, immo suppressants, fibrin,osteoinductive materials, apatite compositions, germicides, fetal cells,stem cells, enzymes, proteins, hormones, cell therapy substances, genetherapy substances, and combinations thereof. These therapeuticsubstances may be combined with the materials used to make the fastenersto produce a composite fastener or implant. Alternatively, thetherapeutic substances may be impregnated or coated on the fastener.Time-released therapeutic substances and drugs may also be incorporatedinto or coated on the surface of the fastener. The therapeuticsubstances may also be placed in a bioabsorbable, degradable, orbiodegradable polymer layer or layers.

In addition to including the materials and agents previously described,a fastener may take the configuration of an integrated fastener and armmember. The flexible arm may be incorporated into the fastener andextend therefrom. The arm may be connected with an end portion of thefastener or with any portion between the end portions, like themidpoint. The fastener and flexible arm may include the same ordifferent materials and/or therapeutic agents. In use with thepositioning device of the present invention, the fastener may bepositioned at the distal end of the hook with the flexible arm extendingfrom the fastener either within the lumen of the hook or exterior to thehook. Once the fastener is properly placed within the body, the flexiblearm may be positioned through or around tissue and/or an implant andtensioned to compress and stabilize the tissue and/or implant. Anotherfastener may be connected with the flexible arm to maintain tension andposition of the arm.

The sutures of the present invention may be made of metallic material,non-metallic material, composite material, ceramic material, polymericmaterial, copolymeric material, or combinations thereof. The sutures maybe degradable, biodegradable, bioabsorbable, or nonbiodegradable.Examples of suture materials are polyethylene, polyester, cat gut, silk,nylon, polypropylene, linen, cotton, PLA, PGA, caprolactam, andcopolymers of glycolic and lactic acid. Preferably, the sutures areflexible or bendable. They may be threadlike, monofilament,multifilament, braided, or interlaced. The sutures may have a coating oftherapeutic substances or drugs. For example, the sutures may includeantibiotics, hydroxypatite, anti-inflammatory agents, steroids,antibiotics, analgesic agents, chemotherapeutic agents, bonemorphogenetic protein, demineralized bone matrix, collagen, growthfactors, autogenetic bone marrow, progenitor cells, calcium sulfate,immo suppressants, fibrin, osteoinductive materials, apatitecompositions, fetal cells, stem cells, enzymes, proteins, hormones, andgermicides.

With the fastener 52 and suture 56 on the distal end of the flexiblepushrod 54, the pushrod 54 is moved distally through the lumen of thehook 24 until the fastener 52 is positioned generally next to the distalopening of the bone passage 48, as seen in FIG. 4. The pushrod 54 may beadvanced to push the fastener 52 beyond the distal aperture 50 of thehook 24 or may be advanced to position the fastener 52 partially in andpartially out of the hook 24. In the latter configuration, the fastener52 may be easily withdrawn, if necessary, from the hook 24 by moving thepushrod 54 proximally.

Alternatively, the fastener 52 and suture assembly may be assembled inthe lumen prior to inserting the device in a patient. For example, asuture may be threaded into the lumen from the distal end of the hook24, or may be inserted through the proximal end as described abovebefore inserting the hook into the patient's body. This allows visualconfirmation of that the fastener is in a desired position beforeintroducing it into the patient's body. The hollow interior of the hook24 may be sized to allow sutures to be placed therethrough, butsufficiently small to preclude the fastener 52 from entering it. Thedistal end may have a bracket or assembly that holds the fastener 52 ina desired position. The bracket or assembly may grip the fastener inplace, such as by an interference fit or with friction. In oneembodiment, application of tensioning forces to the suture helps holdthe fastener 52 in a desired position relative to the distal end of thehook 24.

As illustrated in FIG. 5, a suture claw or grabber 58 is positioned inthe guide channel 32 and through the bone passage 48. A hook, claw, orclip 60 is attached to the distal end of the suture claw 58. When thesuture claw 58 is inserted distally into the guide channel 32, the hookor clip 60 exits or at least partially exits the distal opening of thebone passage 48. Since the fastener 52 is positioned near the distalopening of the bone passage 48, the hook or clip 60 of the suture claw58 can grab or capture the suture 56 extending from the fastener 52. Thesuture 56 may be grabbed by rotating the suture claw 58 and allowing thesuture 56 to wrap around the hook 60 at the distal end of the sutureclaw 58. Alternatively, the suture 56 may be grabbed with a clip 60,like an alligator clip, which may be activated from the proximal end ofthe suture claw 58. In another embodiment, a spiral member, like acorkscrew, may be disposed on the distal end of the suture claw. Thesuture claw may be twisted to thereby allow the spiral member to grabthe suture. It should be understood that the suture claw should grab allthe suture legs or portions attached to the fastener. For example, inFIG. 5, there are two suture legs extending from the fastener. Both legsshould be captured by the suture claw either simultaneously orsequentially.

It is also contemplated that the fastener or suture may be pulled orplaced in position using magnetic or electromagnetic force. For example,once a passage is drill through tissue or an implant, a magnetic may beused to pull a suture through the passage. Alternatively, when using afastener with a flexible arm, the arm may be pulled through the passage.In these embodiments, the suture or flexible arm may include a materialwhich is attracted to a magnet.

As previously described, a passage may not need to be pre-drilled intothe tissue or bone. In this instance, the suture claw may include adistal tip configured for penetrating into and through the tissue. Usinga self-introducing suture claw eliminates the need to bore a passagethrough the tissue before pulling the suture through the tissue.

In FIG. 6, the suture claw 58 is shown retracted from the guide channel32. As the suture claw 58 is retracted, it pulls the suture and/orsuture portions 56 from the lumen of the hook 24 and into the guidechannel 32. As seen in FIG. 7, the proximal ends of the suture portions56 may extend beyond the proximal end of the guide channel 32 when thesuture claw is fully retracted.

As illustrated in FIG. 8, the hook, handle, and drill sleeve of thedrill system are removed from the bone 30. The fastener 52 (not shown)is located on the distal side of the bone 30. The suture 56 extends fromthe fastener 52 through the bone passage and out the proximal opening ofthe bone or tissue passage. In FIG. 9, another fastener 62 is placedaround or otherwise connected with the suture and/or suture portions 56.The suture 56 is tensioned, and the fastener 62 is secured to the suture56 to thereby approximate the fracture and stabilize the bone 30. Thetension of the suture pulls on the fasteners 52 and 62 generally towardseach other, thereby applying pressure to the fractured bone or tissue.

Another exemplary embodiment of the guidance and positioning device 70is illustrated in FIG. 10. The device 70 is shown positioned around afractured bone 30. It should be understood that the device may be usedto fasten any tissue type or combination of tissues as previouslydescribed. The device 70 includes a generally cylindrical handle 22 anda hookshaped elongated member 72 attached to the handle 22. In thisembodiment, the hook-shaped elongated member 72 does not necessarilyinclude a lumen extending therethrough. The proximal portion of thehook-shaped member 72 may be positioned generally parallel with thelongitudinal axis of the handle 22. The device 70 may include a lever,clip, set-screw, button, spring, or latch 26 for securing and releasingthe hook-shaped elongated member 72. The lever 26 allows different sizedhooks to be placed in the handle 22. For example, the hooks may be ofdifferent lengths, have different radii of curvature, or have differenttypes or sizes of bone engagement portions 28.

A guide slot 74 extends through the handle 22 generally parallel withthe longitudinal axis of the handle 22. The longitudinal axis of theguide slot 74 is generally aligned with the distal end of thehook-shaped member 72. The guide slot 74 and hook-shaped member 72 aregenerally parallel and relatively close to each other at and just distalto the handle 22. In this configuration, a single, small, percutaneousincision may be made in skin or other soft tissue to gain access to thefractured bone or other tissue requiring fixation.

In use, the device 70 is positioned with the hook-shaped portion 76 ofthe hook-shaped elongated member 72 placed next to and around the tissueto be fastened. In FIG. 11, the hook-shape portion 76 is placed around afractured bone 30 (fracture not shown). A drill system 36 is positionedin the guide slot. The drill system 36 includes a headpiece 38configured for attachment to a drill 40. A drill bit 42 is positioned atthe distal end of the drill system 36. A drill stop 44 is located distalfrom the headpiece 38 and prevents the drill bit 42 from penetrating toofar beyond the tissue to be drilled. The drill system 36 may be acannulated drill system. The drill system 36 is used to create a passage48 in the bone 30 from the proximal side of the bone 30 to the distalside of the bone 30. The distal opening of the bone passage 48 isgenerally near a socket 78 at the distal end of the hook-shaped portion76 of the elongated member 72.

As previously noted, a drill system may not be needed to form a passagein the tissue. An elongated member with a distal tip configured forpenetrating through tissue may be placed in the guide slot and used forpassage through tissue. The elongate member may be a guide wire, k-wire,needle, or like device.

FIG. 12 illustrates the socket 78 at the distal end of the hook-shapedportion 76 of the elongated member. The socket 78 is dimensioned andconfigured for holding and/or carrying a fastener 52. The socket 78 maybe a hollow cylinder or any other configuration capable of accepting afastener 52. As seen in FIG. 11, the socket 78 is positioned at thedistal end of the hook-shaped member 72 such that the fastener 52 isgenerally aligned with the distal opening of bone passage 48. Thefastener may include characteristics, materials, therapeutic substances,coatings, or any other features as previously described herein. It iscontemplated that the socket may hold the fastener magnetically,frictionally, with an interlocking mechanism such as a snap, withadhesive, etc.

Next, as shown is FIG. 13, the drill system is removed from the guideslot 74. A fastening member 80 is placed in the guide slot 74 andthrough the passage in the bone 30. The fastening member 80 is moveddistally through the passage and inserted into the fastener disposed inthe socket at the distal end of the hook-shaped member 72. The fasteningmember may be made of metal, polymer, ceramic, composite, body tissue,or combinations thereof. The fastening member may also include features,therapeutic agents, and coatings similar to the fastener and suturepreviously described. FIG. 14 illustrates one exemplary embodiment ofthe connection between the fastening member 80 and the fastener 52. Thedistal end of the fastening member includes a threaded portion 82, andthe fastener 52 includes a threaded hole. The fastening member 80 isscrewed into the fastener 52. Other examples of connecting the fasteningmember and fastener include ball and socket, hook and loop, mechanicalexpansion, material expansion, dovetail, orientation change, heatbondable material, biocompatible adhesive, and other similar connectionmeans.

In the embodiment wherein a drill system is not used create a passage inthe tissue, the fastening member 80 may include a sharp or pointeddistal tip to allow the member to be moved through the tissue, free of apassage. Using a self-introducing fastening member may eliminate theneed to pre-drill the passage in the tissue.

As illustrated in FIG. 15, the guidance and positioning device isremoved from the bone 30. The fastener 52 (not shown) is located on thedistal side of the bone 30. The fastening member 80 extends through thebone passage and out the proximal opening of the bone passage. In FIG.16, another fastener 62 is placed around the fastening member 80. Thefastening member 80 is tensioned, and the fastener 62 is secured to thefastener member 80 to thereby approximate the fracture and stabilize thebone 30. Once again, the tension of the fastening member pulls thefasteners toward each other, which in turn causes pressure to be appliedto the treated bone or tissue.

It is further contemplated that the guidance and positioning device 20,70 may be used without a distal fastener. In this embodiment, the device20,70 is used to position a suture on the backside or distal portion ofthe tissue. The suture claw, grabber, or elongate member may be placedin the guide channel or guide slot and moved distally toward the suturelocated at the distal end of the hook. Using the suture claw, one or twosections of the suture may be pulled through the tissue to the proximalside of the tissue. The suture or sutures may be pulled through apre-drilled passage created by a drill system or may be pulled through apassage created by a self-introducing suture claw. Once a portion of thesuture is positioned on the proximal side of the tissue, it may betensioned and secured with a fastener. Alternatively, the proximallyextending suture section may be fastened with another section of thesuture extending from the distal end of the hook and around the tissue.In this embodiment a suture loop is formed with tissue caught orpositioned in the middle of the loop. The two sections of the suture maybe secured with a knot or a fastener.

FIGS. 17 and 18 illustrate exemplary embodiments of clamping mechanismsfor the guidance and positioning device. FIG. 17 shows a tubular clampmember 84 connected with the handle 22 of the device 20,70. The clampmember 84 includes a lumen extending therethrough for allowing passageof the drill system, suture claw, and suture as previously described.The proximal portion of the clamp member 84 includes threads 86, aratchet, or the like for advancing the clamp member 84 into and out ofthe handle 22. The distal end of the clamp member 84 may include atissue pad 88 for contacting tissue.

The tissue pad 88 may be integrally formed on the distal end of theclamp member. For example, during fabrication of the clamp member, itscross-section may initially be relatively the same size along itslength, including at the distal end. Subsequently, the distal end may bedeformed or flattened to have a larger cross section.

Alternatively, the tissue pad 88 also may be connected to the clampmember in a manner that allows it to rotate and/or swivel. As the clampmember 84 is moved toward the bone or tissue, some areas of the tissuepad 88 may begin to make contact even though the clamp member 84 mayrequire additional rotation or advancement in order to obtain a desiredamount of contact. If the tissue pad 88 is able to rotate or swivel, itcan adjust to the contours of the bone or tissue while also reducingpotential abrasion.

The contact surface of the tissue pad 88 may be substantially flat, asshown in FIG. 17, but it also may be curved or have a different shapethat may correspond generally to the curvature or shape of the bone ortissue that it may contact. The contact surface also may be deformableso that it can more easily conform to an uneven surface of bone ortissue. The deformable surface of the tissue pad may be formed from alayer of elastomeric material (e.g., rubber or urethane), foam material,or any other elastomeric material suitable for use in a surgicalprocedure.

In use, the device 20 is positioned about a bone, or other tissue. Theclamp member 84 is moved or rotated distally so that the tissue pad 88contacts the proximal side of the bone. Further advancement of the clampmember 84 causes the tissue pad 88 to apply pressure on the bone ortissue.

Teeth or other friction means 90 may be disposed on the distal portionof the hook 24 to make contact with the distal side of the bone so thatwhen the clamp member 84 extended, the device 20 is clamped or held inposition relative to the bone. The contacting surface of the hook alsomay be modified or configured in the manner described above for thetissue pad.

FIG. 18 shows another embodiment of a clamping mechanism. The tubularclamp member 84 is slideably disposed or connected with the handle 22 ofthe device 20,70. The clamp member 84 may also include a lumen extendingtherethrough. A squeeze/finger grip 92 is connected with the handle 22for advancing and retracting the clamp member 84 relative to the handle22. When the squeeze grip 92 is moved toward the handle 22, the clampmember 84 may be moved or ratcheted distally thereby pressing the tissuepad 88 against the bone or other tissue. In this configuration, theclamp member functions like a come-along with detents and/or teeth. Thesqueeze grip 92 may be moved away from the handle 22 to move the clampmember 84 proximally, or a release button or spring or clip may beactivated to permit the clamp member 84 to move proximally. Teeth orother friction means 90 may be disposed on the proximal side of thesocket 78. With the clamp member 84 extended, the device 70 is held tothe bone or other tissue between the tissue pad 88 and teeth 90 orsocket 78.

Other embodiments of the clamping mechanism are further contemplated.For example, the guidance and positioning device 20,70 may include oneor more inflatable members, such balloons. An inflatable balloon may bepositioned along the hook at a location where the hook passes near theproximal surface of the tissue. That is, the balloon may be located atthe proximal end of the curved portion of the hook. In a deflatedconfiguration, the device may be properly positioned by the physician.The balloon may then be inflated to press against the proximal side ofthe tissue causing the distal end of the hook to press against thedistal side of the tissue and thereby hold or lock the device in place.The balloon may be inflated with air, gas, or liquid. Inflation may bemade manually with a hand pump, electrically with an electric pump orbattery-operated pump, or pneumatically with a pressure cartridge. Theballoon may also help guide the distal end of the hook into the properposition. Multiple balloons may be inflated and/or deflated together orseparately to guide the hook. Also, the balloon(s) may be used to createspace in tissue.

In another example, the device 20,70 may include a balloon at the distalend of the hook. Operation of the balloon may be similar to aspreviously described; however, in the current embodiment, the balloonmay inflate to press against the distal side of the tissue causing theproximal portion of the hook (which may include a tissue pad or grippingteeth) to press against the proximal side of the tissue to thereby holdthe device in position. Furthermore, two or more balloons may be used toposition and hold the device relative to the tissue. The plurality ofballoons may be located along the hook or guide channel and inflatedtogether or individually to properly align and hold the device in place.In addition to holding the device relative to the tissue, the balloon orballoons may compress the tissue, tissue elements, and/or implant. Withthe tissue and/or implant compressed, a fastener or other implant may bepositioned within the body.

As illustrated in FIG. 19, the device 20,70 may include a tensioningmechanism 94 to tension the suture 56 or fastening member 80. Thetensioning mechanism 94 may be attached to the handle 22, tubular member24, elongated member 72, or other component of the device 20,70. Afterthe suture 56 or fastening member 80 is inserted through the passage intissue, like a fractured bone 30, the tensioning mechanism 94 may pulland tension the suture 56 or fastening member 80 while a proximalfastener 62 is positioned to maintain the tension in the suture 56 orfastening member 80. The tensioning mechanism 94 may be, but is notlimited to, two elements which pinch the suture 56 or fastening member80 to pull it proximally or a spool which rotates to pull the suture 56or fastening member 80. A tension gauge, strain gauge, read-out display,tension limiter, and/or an audio or visual tension indicator may be usedto apply the proper tension to the suture or fastening member. Also,measurement of the tension may be accomplished with a spring, aradiofrequency emitting device, and/or a sensor such as an electricalsensor, flexible sensor, compressive sensor, piezoelectric sensor. Otherexamples of tension applicators are disclosed in U.S. Pat. Nos.6,010,525 entitled “Method and Apparatus for Securing a Suture”;6,447,516 entitled “Method of Securing Tissue”; and 6,635,073 entitled“Method of Securing Body Tissue.” The above mentioned patents are herebyincorporated by reference.

As further shown in FIG. 19, the distal portion 96 of the tubular clampmember 84 may be offset or curved thereby exposing the suture 56 orfastening member 80 between the fractured bone 30 and clamp member 84.The tubular clamp member 84 may include a lumen extending therethroughwith the lumen having an aperture at or near the proximal end of theoffset portion 96 or the distal end of the straight section of the clampmember 84. The offset distal portion 96 allows a fastener 62 to beplaced around the suture 56 or fastening member 80 adjacent to theproximal side of the bone 30. When the suture 56 or fastening member 80is tensioned with the tensioning mechanism 94, the fastener 62 may beapplied to maintain the tension in the suture 56 or fastening member 80.

It is contemplated that the guidance and positioning device of thepresent invention may include more than one hook or elongated member forpositioning multiple fasteners at the distal side of tissue. Forexample, as illustrated in FIG. 29, the device 150 may include two hooksor elongated members 152 and 154 attached to the handle 156 andpositioned generally parallel to each other. The handle 156 may theninclude two guide channels, slots, or pins 158 and 160, each beingaligned with one of the distal ends of the hook shaped tubular orelongated members. In this configuration, two passages 162 and 164 maybe drilled in tissue, like a fractured bone 166, and two sutures orfastening members may be positioned through the passages, tensioned, andsecured. One passage 162 may be non-linear while the other passage 164may be linear. Having multiple hooks and guide channels or slots allowsa physician to implant multiple fasteners thereby producing compressionon the implant or tissue, enhancing the healing environment, andallowing for tissue ingrowth. The device with multiple hooks or pins mayalso be used to position other implants disclosed herein, such asadhesives, tissue scaffolds, medicaments, etc.

It is also contemplated that the device of the present invention may bedisposable or may be sterilized after use and reused. The device may bepartly disposable and partly reusable. For example, the handle may bereusable and the hook and/or guide channel may be disposable.Alternatively, the handle may be disposable. The device, its components,fasteners, drill bits, sutures, and other apparatus disclosed herein maybe package in a kit. The kit may be set-up of a specific procedure, suchas repair of a fractured bone, securing of an implant, approximatingbody tissue, etc.

Positioning Implants

The present invention not only provides an instrument and method fordynamic and rigid fastening of tissue, but it also provides for theguidance and positioning of an implant within the body. For example, thepresent invention may be utilized with tissue scaffolds as described inU.S. patent application Ser. No. 10/457,100 entitled “Scaffold andMethod for Implanting Cells” by Peter M. Bonutti. Viable cells may bepositioned on a support structure then implanted within a body. One ormore blood vessels may be connected with the support structure toprovide a flow of blood through the support structure. The devices andmethods of the present invention may be used to guide and position thesupport structure within the body and fasten the scaffold to tissue oranother implant by way of a sling support and/or strut. The abovementioned application is hereby incorporated by reference.

Furthermore, the present invention may be used in combination with amedical system for the administration of a pharmaceutical agent in vivoto a patient. The medical system may include an implant positionable ina body of a patient. A pharmaceutical agent may be disposed on themedical implant and at least partially coated with a reactive coating.The reactive coating acts to control the release of the pharmaceuticalagent. An energy unit may be provided for transmitting an energy signalto the reactive coating, wherein the reactive coating reacts to theenergy signal to control the release rate of the pharmaceutical agent.Additionally, the energy unit may also heat up the treatment site,locally increasing vascularity at the treatment site and allowingthermal necrosis of tissue. The localized increasing in temperatureincreases the permeability of the local tissue, allowing for anincreased and more efficient adsorption of the pharmaceutical agent intothe treatment site. Additionally, in response to localized increase intemperature, which can be perceived as physical damage or an infectionto the local area, the local cells may release beneficial proteins,enzymes, hormones, etc.

In another embodiment, a pharmaceutical agent, drug, or medicament maybe delivered within the body using the positioning device describedherein. The hook and/or guide channel of the positioning device mayconduct the passage of a medicament to a specific location within thebody. The drug may be transported through the lumen of the hook or guidechannel or, alternatively, may be placed on the exterior of the hook orguide channel. When the positioning device has been properly aligned,the medicament may be released in a constant stream or in a pulsatilemanner. Examples of medicaments that may be used with the presentinvention include those disclosed throughout this application and,additionally, but not limited to, an anti-inflammatory agent,non-proliferative agent, anti-coagulant, anti-platelet agent, TyrosineKinase inhibitor, anti-infective agent, anti-tumor agent, anti-leukemicagent, and combinations thereof. One or more medicaments may be placedin one or more reservoirs which are in fluid communication with thepositioning device. The reservoir may be physically separate from thedevice with tubing interconnecting the device and reservoir.Alternatively, the reservoir may be integrated into or attached to thepositioning device. Release of the medicament may be achieved throughmanual operation such as with a plunger, air pressure, or valve orthrough electrical operation such as with a pump or valve. Themedicament may be released from the positioning device or remotely awayfrom the device as with a radiofrequency or signal emitting device.

It is contemplated that an adhesive may be delivered within the body inthe way a medicament is delivered as described above. The adhesive coulda polysaccharide based adhesive, fibrin adhesive, mollusc basedadhesive, cyanoacrylate based adhesive, polymeric based adhesive, orother biocompatible adhesive. The adhesive could be thermally activatedor pH activated. The adhesive could be a single part adhesive or a twopart adhesive requiring both parts to activate the adhesive. Theadhesive may also be hydrophilic or include hydrophilic material. Thehydrophilic adhesive/material may expand upon imbibing liquid, such asbody fluid. In use, the adhesive may be delivered within the body tobond tissue together such as soft tissue to soft tissue, soft tissue tohard tissue, or hard tissue to hard tissue. For example, portions of afractured bone may be adhered, a muscle may be bonded to other muscle orto a tendon, and a ligament may be adhered to another ligament, tomuscle, and/or to bone. The adhesive may also be used to bond an implantwith body tissue or to another implant. For example, a bone or jointreplacement component may be adhered to another replacement component orto other bone, tissue scaffolding with cells may be bonded to othertissue or other scaffolding, and fasteners may be adhered to tissue orsutures.

In another embodiment, an energy sink, such as a pH sink, may beincorporated into a medical implant or be positioned separate from themedical implant. The pH sink is configured to absorb energy from theenergy unit, releasing a chemical to either increase or decreasing thelocal pH. The change in local pH can either increase or decrease thedegradation rate of a degradable polymer coating, which in turn cancontrol the release rate of a pharmaceutical agent. The pH sink can beformed from calcium carbonate. Additionally, the localized change in pHcreated by the pH sink has beneficial effects, which include (but arenot limited to): aiding in the alleviation of localized pain, fightingof local infections, and increasing vascular flow and permeability ofvessels at the treatment site to control delivery of pharmaceuticalagent.

For example, a localized increasing in pH increases the permeability ofthe local tissue, allowing for an increased and more efficientadsorption of the pharmaceutical agent into the treatment site. Theenergy sink may also be used to induce the release of beneficialenzymes, proteins, hormones, etc. from the cells in the treatment site.A localized increase in acidity and/or temperature can be perceived as aphysical damage or an infection to the local area. In response, to thelocal cells may release beneficial proteins, enzymes, hormones, etc. Thepositioning device and method of the present invention may be used toguide and position a drug-eluting implant, a heat sink, or pH sinkwithin the body.

The present invention may also be used with the disclosure of U.S.Provisional Patent Application No. 60/622,095 entitled “Devices andMethods for Stabilizing Tissue and Implants” by Peter M. Bonutti. Theprovisional application discloses various procedures for repairing,reconstructing, and stabilizing tissue and implants within the body.Examples of such tissue include bone, muscle, ligament, tendon, skin,organ, cartilage, and blood vessels. Examples of implants include anorgan, partial organ grafts, tissue graft material (autogenic,allogenic, xenogenic, or synthetic), a malleable implant like a sponge,mesh, bag/sac/pouch, collagen, or gelatin, or a rigid implant made ofmetal, polymer, composite, or ceramic. Other implants include breastimplants, biodegradable plates, metallic fasteners, rods, plates,screws, screw strips, spacers, cages, compliant bearing implants for oneor more compartments of the knee, nucleus pulposus implant, stents,meniscal implants, tissue grafts, tissue scaffolds, biodegradablecollagen scaffolds, polymeric or other biocompatible scaffolds,abdominal hernia meshes, cochlear implants, tracheal implants, smallintestine submucosal grafts, TISSUEMEND scaffolds, prostheses,nanotechnology devices, sensors, emitters, radiofrequency emittingdiodes, computer chips, RFID (radiofrequency identification) tags,adhesives, and sealants.

The guidance and positioning device of the present invention may be usedto stabilize or fasten these implants and tissues. For example, thespine may be repaired or stabilized with fasteners, sutures, and cablesto provide flexible or rigid reinforcement of the joints of the spine.Also, the nucleus pulposus of an intervertebral disc may be repaired orreplaced using the guidance and positioning device of the presentinvention. For example, a prosthetic disc nucleus is positioned betweentwo vertebral bodies and may be secured to surrounding tissue withfasteners and sutures. Additionally, the annulus may be repairedfollowing a nucleus pulposus repair or replacement. The positioningdevice of the present invention may be used to position a fastener andsuture on the internal side of the annulus. The suture may be pulledproximally through the annulus, tensioned, and secured with anotherfastener. Finally, the tissue alignment sleeves disclosed in theprovisional application may be guided and positioned with the instrumentand methods of the present invention. The above mentioned provisionalapplication is incorporated herein by reference.

It is contemplated that the present invention may be utilized with thetracheal tube positioning apparatus of U.S. patent application Ser. No.09/728,553 entitled “Tracheal Intubation” by Peter M. Bonutti. Thatapplication discloses positioning apparatus located relative to apatient's trachea by engaging the patient's trachea. Indicia onrelatively movable sections of the positioning apparatus provide anindication of the distance between the patient's mouth and the patient'slarynx. A flexible guide rod is moved through a distance correspondingto the distance between the patient's mouth and larynx, as determined bythe positioning apparatus. A magnet is utilized to attract a leading endportion of the guide rod. A plurality of emitters may be disposed in anarray around the patient's trachea. Outputs from the emitters aredetected by a detector connected with the tracheal tube. The abovemention patent application is hereby incorporated by reference.

Drill/Sleeve Combination

In another embodiment of the present invention, a drill bit and sleevecombination 100 is provided. In the following description, the drill bitand sleeve combination or system 100 is explained with reference to thefixation of two bones, like two portions of a fractured bone. It shouldbe understood that the present embodiment may be utilized for fasteningor securing tissue to tissue, an implant to tissue, or an implant to animplant.

In FIG. 20 the system 100 includes a tubular member or sleeve 102 foraligning two portions of bone located on opposite sides of a fracture. Adrill bit 104 extends through the longitudinal lumen of the sleeve 102.The distal portion 106 of the drill bit 104 has one or more pivotingblades 108. The system 100 may also include a pusher means 110 forinserting the sleeve 102 into the bone passage created by the drill bit104. The pusher means 110 may be connected to the sleeve, bit, or thedrill. Preferably, a portion of the pusher means 110 does not rotatewith the bit or drill so that the sleeve 102 is not rotated as thepusher means 110 contacts the sleeve 102 during the drilling operation.Examples of the pusher means 110 include a washer-shaped member ordonut-shaped member positioned over the bit or a U-shaped forkpositionable around the shaft of the bit. The lower side of the pushermeans 110 may be configured for contact with the proximal end of thesleeve, while the upper side of the pusher means 110 may be configuredof applying a distal force with a hand, hammer, or press.

As seen in FIG. 21, the blades 108, when extended from the bit 104,increase the drilling diameter of the bit 104. The bone passage createdby the drill bit 104 and the extended blades 108 has a diametergenerally equal to the outside diameter of the sleeve 102. The blades108, when retracted, pivot into or against the distal portion 106 of thebit 104. The diameter of the drill bit 104 with the blades 108 retractedis slightly less than the inside diameter of the sleeve 102.

The pivoting blades 108 of the system 100 may be connected with thedistal portion 106 of the bit 104 in a variety of ways, but preferably,the blades 108 are pivotally attached to the bit 104. In one exemplaryembodiment as seen in FIGS. 20 and 21, the blades 108 extend and retractalong radial axes of the bit 104. The blades 108 may pivot downwardly ordistally into an extended configuration and may pivot upwardly orproximally into a retracted configuration. In the retracted state, theblades 108 may be positioned within a groove or notch within the distalportion 106 of the bit 104. Furthermore, the blades 108 may be springloaded to normally reside in the retracted configuration. When the drillbit 104 is rotated with a drill, the centrifugal force generated by thedrill may cause the blades 108 to pivot into the extended configuration.Once in the extended position, the blades 108 may be locked intoposition to allow drilling or cutting of the bone.

In another exemplary embodiment, the blades 108 may be manually pivoteddistally and proximally. A pin or shaft may extend along the center ofthe drill bit 104 with the distal end of the pin in contact with theblades 108. As the pin moved longitudinally, the blades 108 may extendand retract. The proximal portion of the pin may include a lever orother means for moving or advancing the pin along the center axis of thebit 104.

It is further contemplated that the blades 108 may be extended andretracted radially in and out of the distal portion of the bit 104 alonga linear path instead of being pivoted as previously described. In thisembodiment, the blades 108 may extend with centrifugal force and retractwith a spring-like mechanism or may be manually extended and refractedwith a pin or shaft along the central axis of the bit 104. Furthermore,other embodiments of the blades are contemplated. For example, theblades may be generally arch-shaped to conform to the outsidecircumference of the bit. The distal ends of the blades may be pivotallyattached to the bit allowing the blades to extended radially outward formaximum cutting diameter or retract against the outer surface of the bitto minimize the bit diameter.

FIGS. 22 and 23 illustrate the drill bit and sleeve system 100 in use torepair a fractured bone 112. The drill bit 104 is inserted into thelumen of the sleeve 102. The distal portion 106 of the bit 104 and thepivoting blades 108 extend beyond the distal end of the sleeve 102.Preferably, the amount of bit 104 extending from distal end of thesleeve 102 is minimized to prevent damage to soft tissue of the distalside of the bone 112. The proximal portion of the bit or shank 114extends from the proximal end of the sleeve 102 and is connected to adrill 116. The pivoting blades 108, located beyond the distal end of thesleeve 102, are in the extended configuration. The bit 104 is rotatedand advanced distally through the fractured bone 112. As the bit 104advances and creates a passage in the bone 112, the sleeve 104 is moveddistally into the passage with the pusher means 110. The sleeve 102 istight or snug within the passage since the diameter of the passage isgenerally equal to the outside diameter of the sleeve 102. When thesleeve 102 is in its proper position securing the bone portions 118 and120 of the fractured bone 112, and the drill bit 104 may be removed fromthe lumen of the sleeve 102. The bit 104 may be pulled from the lumen ofthe sleeve 102 because the blades 108 may be positioned in the retractedconfiguration giving the drill bit 104 a diameter generally smaller thanthe diameter of the lumen of the sleeve 102. With the sleeve 102 inplace, the bone is compressed, and the fracture is stabilized.

In another embodiment of the present invention, the drill bit and sleevecombination or system 100 is dimensioned and configured fortransformation into a fastener. As shown in FIGS. 24 and 25, the system100 includes the tubular member or sleeve 102, the pusher means 110, anda drill bit 104 with an expanding distal portion 122. The drill bit 104extends through the lumen of the sleeve 102 with the distal portion 122of the bit 104 extending beyond the distal end of the sleeve 102. Thecutting diameter of the distal portion 122 of the bit 104 is generallyequal to the outside diameter of the sleeve 102. In this embodiment, thedistal portion 122 of the bit 104 does not include pivoting cuttingblades. However, the distal portion 122 does include means for expansionto a diameter greater than the cutting diameter.

Some examples of expansion means are shown in FIGS. 26-28. In FIG. 26the expansion means includes one or more mechanically extending barbs126 from the distal portion 122 of the bit 104. When extended orexpanded, the barbs 126 increase the overall diameter of the drill bit104. The barbs 126 may extend to the outside diameter of the sleeve 102,but preferably the barbs 126 extend beyond the outside edge of thesleeve 102. Most preferably, the barbs 126 extend over or into thedistal side of the fractured bone 112. In the expanded configuration,the drill bit 104 is prevented from being pulled proximally out of thesleeve 102.

In FIG. 27, the expansion means includes a distal portion 128 of thedrill bit 104 which pivots. In a first orientation during a drillingprocedure, the distal portion 128 of the bit 104 is generally in-linewith rest of the drill bit 104. After drilling, the distal portion 128of the bit 104 is rotated about a pivot point into a second orientation.In the second orientation, the distal portion 128 is generallyperpendicular to the rest of the drill bit 104. As a result, the endsections 132 and 134 of the pivoted distal portion 128 of the bit 104extend beyond the outer diameter of the sleeve 102. Preferably, the endsections 132 and 134 extend over or into the distal side of thefractured bone 112 to prevent the bit 104 from being pulled from thesleeve 102.

In FIG. 28, the expansion means includes a distal portion 136 of the bit104 which has two or more longitudinal sections 138 and 140 that arebiased radially outward. The longitudinal sections 138 and 140 may benormally biased outward but held together by the lumen of the sleeve 102when drilling through the bone 112. Alternatively, the longitudinalsections 138 and 140 may be normally in a non-biased configuration.After the passage is drilled in the bone 112, a plunger 142 within thedrill bit 104 may be moved distally biasing the longitudinal sections138 and 140 radially outward. With the longitudinal sections 138 and 140biased, the distal portion 136 of the bit 104 may extend over or intothe distal side of the fractured bone 112 to secure the bit 104 withinthe sleeve 102 and bone passage.

The drill bit and sleeve system 100 which transforms into a fastener maybe utilized to secure various tissue and implants. Generally, in use,the drill bit 104 is inserted into the lumen of the sleeve 102 with thedistal portion of the bit 104 extending beyond the distal end of thesleeve 102. The proximal portion of the bit or shank 114 extends fromthe proximal end of the sleeve 102 and connects to a drill. The bit 104is rotated and advanced distally through the fractured bone 112. As thebit 104 advances and creates a passage in the bone 112, the sleeve 102is moved distally into the passage with the pusher means 110. When thesleeve 102 is in its proper position connecting the two portions 118 and120 of a fractured bone 112, the shank 114 of the drill bit 104 isremoved from the drill. The distal portion of the bit 104, which extendsjust beyond the distal surface of the bone 112, is expanded with theexpansion means.

Once expanded, the drill bit 104 is prevented from being pulled out ofthe bone passage. A retainer 144 may then be placed around the shank 114of the bit 104 and moved distally to engage the proximal side of thebone 112. The retainer 144 is secured to the shank 114. With the distalportion of the bit expanded and the retainer connected to the shank, thedrill bit (and the sleeve) is transformed into a fastener which holdsthe fractured bone in compression. It is also contemplated that thedrill bit may be used without the sleeve so that the drill bit alonebecomes a fastener.

The tubular member or sleeve of the present invention is generallytubular shaped having a wall with an inner surface and an outer surface.The inner surface defines a lumen which is dimensioned and configuredfor receiving a drill bit, suture, cable, K-wire, or similar device. Thesleeve may include a slit through the tubular wall. The slit allows thesleeve to be decreased in diameter for implantation and increased indiameter after implantation for proper alignment of the implantationsite. In a further embodiment, the sleeve may include two slits in thetubular wall thereby forming two semi-tubular members. The semi-tubularmembers may be placed separately at the implantation site then alignedto form a complete tubular member. In another embodiment, the tubularmember is a solid member.

The tubular member or sleeve may be flexible to enable the tubularmember to be inserted into a linear or nonlinear passage through thebone. The tubular member may be formed of metallic material, compositematerial, ceramic material, polymeric material, or combinations thereof.The sleeve may be made from a degradable, biodegradable, bioerodible, orbioabsorbable material, such as a polymer, composite, or ceramic. Thetubular member may also include a therapeutic substance to form acomposite tubular member, or the therapeutic substance may be coatedonto the tubular member. Furthermore, therapeutic substances or graftmaterial (autogenic, allogenic, xenogenic, or synthetic) may be packedinto the sleeve.

Additionally, the outer surface of the tubular member may include afriction or gripping means. A portion of the outer surface of thetubular member may include threads, raised pebbles, bumps, raisedridges, or hills. In addition to a friction means on the outer surfaceof the tubular member, the wall of the sleeve may include openings fortissue ingrowth. The tubular member of the present invention is furtherdescribed in U.S. Provisional Patent No. 60/622,095 entitled “Devicesand Methods for Stabilizing Tissue and Implants,” which is herebyincorporated by reference.

Guidance and Navigation

The guidance and positioning device of the present invention may beplaced within the body of a patient with precise navigation. Forexample, one or more guide wires or k-wires may be utilized—one to holdthe device in position and a second wire to drill or pass through tissuetoward the distal end of the hook of the device. One of the guide wiresor an additional wire can be used to pull a suture or fastener throughthe tissue. Alternatively, the positioning device may be positionedthrough an expanding retractor with percutaneous guidance.

Other navigation techniques for precise placement of the positioningdevice of the present invention include endoscopic guidance, magneticresonance imaging, CT scan, ultrasound, fluoroscopy, X-ray, computerassisted navigation, magnetic guidance, electromagnetic guidance,radiofrequency guidance, optical guidance, and laser guidance. Forexample, the hook and/or guide channel of the positioning device mayinclude a magnet, a radiofrequency emitter, or a thermal emitter/sensor.U.S. patent application Ser. No. 10/191,751 entitled “Method ofPerforming Surgery” discloses computer assisted navigation. In usingcomputer assisted navigation with the present invention, emitters,receivers, and/or reflectors may be attached to the positioning deviceand/or tissue. The computer navigation system may utilize multipleseparate registers which have optical feedback to a central unit. Thecomputer navigation system may utilize electromagnetic or photo-opticalfeedback. U.S. Pat. Nos. 5,329,924 entitled “Sequential ImagingApparatus”; 5,349,956 entitled “Apparatus and Method for Use in MedicalImaging”; and 5,542,423 entitled “Indexing Assembly for Joint Imaging”disclose further devices and methods for use in medical imaging. Also,the present invention may be performed using robotics, such as hapticarms or similar apparatus. The above mentioned patents and applicationsare hereby incorporated by reference.

It is contemplated that the device and method of the present inventionbe applied using minimally invasive incisions and techniques to preservemuscles, tendons, ligaments, bones, nerves, and blood vessels. A smallincision(s) may be made adjacent the target area to be repaired, and atube, delivery catheter, sheath, cannula, or expandable cannula may beused to perform the methods of the present invention. U.S. Pat. No.5,320,611 entitled “Expandable Cannula Having Longitudinal Wire andMethod of Use” discloses cannulas for surgical and medical useexpandable along their entire lengths. The cannulas are inserted throughtissue when in an unexpanded condition and with a small diameter. Thecannulas are then expanded radially outwardly to give a full-sizeinstrument passage. Expansion of the cannulas occurs against theviscoelastic resistance of the surrounding tissue. The expandablecannulas do not require a full depth incision, or at most require only aneedle-size entrance opening. The above mentioned patent is herebyincorporated by reference.

Also, U.S. Pat. Nos. 5,674,240; 5,961,499; and 6,338,730 disclosecannulas for surgical and medical use expandable along their entirelengths. The cannula has a pointed end portion and includes wires havingcores which are enclosed by jackets. The jackets are integrally formedas one piece with a sheath of the cannula. The cannula may be expandedby inserting members or by fluid pressure. The cannula is advantageouslyutilized to expand a vessel, such as a blood vessel. An expandablechamber may be provided at the distal end of the cannula. The abovementioned patents are hereby incorporated by reference.

The present invention may also be utilized with minimally invasivesurgery techniques disclosed in U.S. patent application Ser. No.10/191,751 and U.S. Pat. Nos. 6,702,821 and 6,770,078. These patentdocuments disclose, inter alia, apparatus and methods for minimallyinvasive joint replacement. The femoral, tibial, and/or patellarcomponents of a knee replacement may be fastened or locked to each otherand to adjacent tissue using fasteners disclosed herein and incorporatedby reference. Furthermore, the methods and devices of the presentinvention may be utilized for repairing, reconstructing, augmenting, andsecuring tissue or implants during and “on the way out” of a kneereplacement procedure. For example, the anterior cruciate ligament andother ligaments may be repaired or reconstructed; quadriceps mechanismsand other muscles may be repaired. The patent documents mentioned aboveare hereby incorporated by reference.

Furthermore, it is contemplated that the present invention may be usedwith bariatric surgery, gastric stapling, colorectal surgery, plasticsurgery, gastroesophageal reflex disease (GERD) surgery, ligamentreconstruction surgery (such as the anterior cruciate ligament, ACL), orfor repairing hernias. A band, mesh, or cage of synthetic material orbody tissue may be placed around an intestine or other tubular bodymember. The band may seal the intestine. This method may be performedover a balloon or bladder so that anastomosis is maintained. The innerdiameter of the tubular body part is maintained by the balloon. Theouter diameter of the body part is then closed or wrapped with a band,mesh, or patch. The inner diameter of the tubular body member may benarrowed or restricted by the band. The band may be secured to thetubular body part or surrounding tissue with the device and method ofthe present invention.

It is further contemplated that the present invention may be used inconjunction with the devices and methods disclosed in U.S. Pat. Nos.5,329,846 entitled “Tissue Press and System” and 5,269,785 entitled“Apparatus and Method for Tissue Removal.” For example, an implantsecured within the body using the present invention may include tissueharvested, configured, and implanted as described in the patents. Theabove mentioned patents are hereby incorporated by reference.

Additionally, it is contemplated that the device and method of thepresent invention may be used with heat bondable materials as disclosedin U.S. Pat. No. 5,593,425 entitled “Surgical Devices Assembled UsingHeat Bondable Materials.” For example, fasteners may include heatbondable material. The material may be deformed to secure tissue or holda suture or cable. The fasteners made of heat bondable material may bemechanically crimped, plastically crimped, or may be welded to a sutureor cable with RF (Bovie devices), laser, ultrasound, electromagnet,ultraviolet, infrared, electro-shockwave, or other known energy. Thewelding may be performed in an aqueous, dry, or moist environment. Thewelding device may be disposable, sterilizable, single-use, and/orbattery-operated. The above mentioned patent is hereby incorporated byreference.

Moreover, the device and method of the present invention may be used forthe repair and reconstruction of a tubular pathway like a blood vessel,intestine, urinary tract, esophagus, or similar tubular body parts. Forexample, a blood vessel may be intentionally severed during a surgicaloperation, or the blood vessel may be damaged or torn as a result of aninjury. Flexible fixation of the vessel would permit the vessel tofunction properly and also compress and stabilize the vessel forenhanced healing. To facilitate the repair or reconstruction of a bodylumen, a balloon may be inserted into the lumen and expanded so thedamaged, severed, or torn portion of the vessel is positioned againstthe outer surface of the inflated balloon. In this configuration, thepositioning device of the present invention may be used then toapproximate the damaged portion of the vessel.

Radiofrequency Identification

The devices, fasteners, and other apparatus disclosed herein may includeRFID (radiofrequency identification) tags. Moreover, any surgicaldevice, described herein or not, such as surgical instruments, implants,trays, sponges, screws, bolts, plates, knives, scalpels, etc. mayinclude RFID emitting chips. RFID provides for inventory control before,during, and after surgery. Objects with RFID chips/tags which arelocated under sterile drapes or within sterile containers may be easilylocated without having to break the sterile environment. Also, surgicaldevices and instruments stored in cabinets or placed in an operatingroom may be scanned with an RFID receiver to help technicians and nursesquickly identify location, type, and quantity. RFID chips/tags placed onsurgical objects may save significant time and money during surgery andinventory. Furthermore, matching RFID chips/tags may be placed on aninstrument/device and on the tray which holds the device. Using the RFscanner/transmitter, the correct placement of the device can bedetermined. It is further contemplated that the kits previouslydescribed may include RFID chips/tags placed on the container and thecomponents therein.

Surgical Tools

In another exemplary embodiment, the guidance and positioning device ofthe present invention may be used with pneumatic operated surgicalinstruments. For example, a gas-powered drill may be couple with thechannel guide and/or handle of the positioning device. A surgeon mayoperate the drill by activating a switch to start the fluid of gas whichrotates an air motor thereby rotating a drill bit. The drill may beconnected to a compressed gas source with tubing. However, preferably,the drill includes a connecting port for attaching a gas cartridge orcanister. Such a drill would be free from electrical and battery powerand free from encumbering wires and hoses. The gas cartridge may besized to fit within the drill body or attached externally on the drillbody. The cartridge may be refillable or disposable. In addition to thedrill being gas-powered, the clamping mechanism of the positioningdevice may be gas-powered. By activating the flow of gas, the clamp maybe moved to engage and compress tissue and/or an implant, holding thetissue and/or implant in place until fasteners may be inserted. It isfurther contemplated that other surgical tools, such as saws, shavers,reamers, grinders, etc., may include gas cartridges as previouslydescribed. These gas-powered tools may also include a microprocessor forcontrol and feedback.

All references cited herein are expressly incorporated by reference intheir entirety.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed herein above. In addition, unless mention was made above tothe contrary, it should be noted that all of the accompanying drawingsare not to scale. A variety of modifications and variations are possiblein light of the above teachings without departing from the scope andspirit of the invention.

What is claimed is:
 1. A deformable fastener system comprising: aflexible hollow fastener fabricated solely from a plurality ofbiocompatible fibers; a suture extending through the hollow fastenersuch that two legs of the suture extend from the hollow fastener toenable a user to tension the suture, wherein at least a portion of thesuture is fabricated with polyethylene; and an introducer having apushrod configured to engage the fastener and position the fastenerrelative to a body tissue, wherein the hollow fastener and suture arepositioned on the distal end of the pushrod, and wherein the hollowfastener is configured to deform from a first configuration to a secondconfiguration to provide an anchor for the suture as the suture istensioned relative to the body tissue; and wherein the hollow fastenerincludes a polymeric material.
 2. The system of claim 1, wherein thesuture includes at least a portion of polyester.
 3. The system of claim1, wherein the hollow fastener is knotless.
 4. The system of claim 1,wherein the suture is positionable through proximal and distal portionsof body tissue.
 5. The system of claim 1, wherein the pushrod isflexible.
 6. The system of claim 1, wherein the introducer has at leastone of a linear configuration and a curved configuration.
 7. The systemof claim 1, wherein the distal portion of the introducer is configuredto penetrate an imperforate surface of the body.
 8. A deformablefastener system comprising: a suture; a flexible hollow fastenerfabricated solely from a plurality of fibers comprised of abiocompatible polymeric material, wherein at least a portion of thesuture extends through the hollow fastener such that two legs of thesuture extend from the hollow fastener to enable a user to tension thesuture to deform the hollow fastener from a first configuration to asecond configuration to anchor the suture within the body; and anintroducer with a pushrod configured to engage the fastener, wherein thehollow fastener and suture are positioned on the distal end of thepushrod.
 9. The system of claim 8, wherein the suture is at least one ofbraided and interlaced.
 10. The system of claim 8, wherein the sutureincludes polyethylene.
 11. The system of claim 8, wherein the sutureincludes at least a portion of polyester.
 12. The system of claim 8,wherein the pushrod is flexible.
 13. The system of claim 8, wherein theintroducer has at least one of a linear configuration and a curvedconfiguration.
 14. A method of using a deformable fastener system, saidmethod comprising: inserting a deformable hollow fastener into a passagein a bone, the deformable hollow fastener being flexible and fabricatedsolely from a plurality of flexible biocompatible fibers, and having asuture extending through the deformable hollow fastener such that twolegs of the suture extend from the deformable hollow fastener to enablea user to tension the suture, wherein the deformable hollow fastener andsuture are positioned on the distal end of a pushrod during insertion;tensioning the suture to anchor the deformable hollow fastener into thebone; deforming the deformable hollow fastener from a firstconfiguration to a second configuration in the bone; and whereininserting a deformable hollow fastener further comprises inserting adeformable hollow fastener that includes a polymeric material.
 15. Themethod of claim 14, wherein inserting a deformable hollow fastenerhaving a suture further comprises inserting a deformable hollow fastenerhaving a suture that is at least one of braided and interlaced.
 16. Themethod of claim 14, wherein inserting a deformable hollow fastenerhaving a suture further comprises inserting a deformable hollow fastenerhaving a suture that includes at least one of polyethylene andpolyester.
 17. The method of claim 14, wherein inserting a deformablehollow fastener further comprises inserting a deformable hollow fastenerwith a pushrod that is flexible.
 18. The method of claim 14, whereininserting a deformable hollow fastener further comprises inserting adeformable hollow fastener with an introducer that has at least one of alinear configuration and a curved configuration.
 19. The system of claim8, wherein the hollow fastener is knotless.
 20. The method of claim 14,wherein inserting a deformable hollow fastener further comprisesinserting a deformable hollow fastener that is knotless.